Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery

In patients undergoing cardiac surgery, perioperative anemia is an important factor in surgical recovery. In addition to the low preoperative hemoglobin level, the delayed recovery of the postoperative hemoglobin level is an important problem affecting the incidence of postoperative anemia. Erythroferron is the early response to of the red blood cell production in stressful situations such as anemia, bleeding, and hypoxia. Therefore, it is thought that acute blood loss and systemic inflammatory reaction that inevitably occurs after cardiac surgery will synthesize erythroferron, which helps to restore hemoglobin level at postoperative period by promoting hematopoiesis by simultaneously inhibiting hepcidin and activating hematopoiesis.

In this study, the investigators will investigate the association between Erythroferron and perioperative hemoglobin levels in patient undergoing heart valve surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Anemia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients older than 20 years
undergoing elective valvular heart surgery

Exclusion criteria

Emergency operation
Co-operation with other surgeries
Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
Patients requiring mechanical ventilator care in preoperative period
Patient with severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
Patients with preoperative infection status (Eg. Sepsis)
Patients with acute bleeding status
Hemoglobin concentration below 10g/dL
Disease directly affecting hematopoiesis (eg. Leukemia, myeloma, aplastic anemia)
Uncompensated liver cirrhosis, acute hepatitis, alcoholics
Patients who participated in other clinical studies that could affect prognosis
Patients who cannot understand the informed consent (eg. Foreigner)

Treatment and study plan

Primary outcomes

Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery

Time frame: immediate after surgery, POD1, POD2, POD7, first outpatient vist after discharge (until 6 months)

Compare the change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery, by dividing the groups according to the level of erythroferron immediately after surgery. The amount of change will be compared based on the lowest level of hemoglobin during the time point after surgery. Since investigators planed to compare the recovery rate as well as the amount of recovery at each time point, investigators planed to record the change of hemoglobin at each time point based on the lowest hemoglobin level after surgery.

Secondary outcomes

Change in serum erythropoietin (EPO) level

Time frame: From baseline (preoperative) to 6 months postoperatively

Serum erythropoietin concentration will be measured using a quantitative ELISA assay and reported as mIU/mL. Changes in EPO level from baseline to 6 months will be compared among ERFE tertile groups.
Change in serum hepcidin level

Time frame: From baseline (preoperative) to 6 months postoperatively

Serum hepcidin concentration will be measured using liquid chromatography-mass spectrometry (LC-MS) and reported as ng/mL.
Change in hemoglobin (Hb) concentration

Time frame: From baseline (preoperative) to 6 months postoperatively

Hemoglobin will be measured using an automated hematology analyzer and reported as g/dL.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: May 20, 2022
Registry last updated: Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed